Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Drug: AC2993 7.5 mcg; Drug: Placebo 0.03 mL; Drug: Placebo 0.01 mL; Drug: Placebo 0.04 mL; Drug: AC2993 2.5 mcg; Drug: Placebo 0.02 mL; Drug: AC2993 10.0 mcg; Drug: AC2993 5.0 mcg

• Registration Number: NCT00044694
• Lead Sponsor: AstraZeneca

Brief Summary

This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2002-09-03
• Study First Submitted QC: 2002-09-04
• Study First Posted: 2002-09-05
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Subjects with type 2 diabetes
• Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
• BMI 27-45 kg/m^2
• HbA1c between 7.0 % and 8.0 %

Exclusion Criteria

• Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
• Patients previously treated with AC2993
• Patients presently treated with insulin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC2993 7.5 mcg	AC2993 7.5 mcg	2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL
Placebo 0.03 mL	Placebo 0.03 mL	2 week placebo lead-in followed by Placebo 0.03 mL
Placebo 0.01 mL	Placebo 0.01 mL	2 week placebo lead-in followed by Placebo 0.01 mL
Placebo 0.04 mL	Placebo 0.04 mL	2 week placebo lead-in followed by Placebo 0.04 mL
AC2993 2.5 mcg	AC2993 2.5 mcg	2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL
Placebo 0.02 mL	Placebo 0.02 mL	2 week placebo lead-in followed by Placebo 0.02 mL
AC2993 10.0 mcg	AC2993 10.0 mcg	2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL
AC2993 5.0 mcg	AC2993 5.0 mcg	2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28	Baseline (Day 1) to Day 28	Change in HbA1c from Baseline (Day 1) to study termination (Day 28)

Secondary Outcome Measures

Name	Time	Method
Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28	Baseline, Day 14, Day 28	Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Change in HbA1c from Baseline to Day 14	Baseline, Day 14	Change in HbA1c from Baseline (Day 1) to Day 14
Change in fasting plasma glucose from Baseline to Day 14 and to Day 28	Baseline, Day 14, Day28	Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)

Trial Locations

Locations (32)

Carolina Advanced Research; 🇺🇸 Cary, North Carolina, United States

Fallen Timbers Internal Medicine, LLC; 🇺🇸 Maumee, Ohio, United States

Utah Diabetes Center at the University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Innovative Clinical Trials; 🇺🇸 Birmingham, Alabama, United States

Radiant Research-Gainsville; 🇺🇸 Gainsville, Florida, United States

Innovative Health Research; 🇺🇸 Las Vegas, Nevada, United States

Bautista Research and Medical Clinic; 🇺🇸 Fresno, California, United States

Diagnostic Clinic; 🇺🇸 Clearwater, Florida, United States

Anshutz Outpatient Pavilion; 🇺🇸 Aurora, Colorado, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Radiant Research-Pinellas Park; 🇺🇸 Pinellas Park, Florida, United States

Radiant Research-Boise; 🇺🇸 Boise, Idaho, United States

Radiant Research-Honolulu; 🇺🇸 Honolulu, Hawaii, United States

Cedar-Crosse Research Center; 🇺🇸 Chicago, Illinois, United States

Northshore Medical Research, LLC; 🇺🇸 Covington, Louisiana, United States

Medical Research Institute; 🇺🇸 Slidell, Louisiana, United States

Melvin Kramer, MD; 🇺🇸 Concord, Massachusetts, United States

Radiant Research-Edina; 🇺🇸 Edina, Minnesota, United States

Mississippi Medical Research, LLC; 🇺🇸 Gulfport, Mississippi, United States

Millenium Research; 🇺🇸 Benbrook, Texas, United States

Baylor College of Medicine/Clinical Studies Unit; 🇺🇸 Houston, Texas, United States

The Center for Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States

Endocrinology Clinic of O.C.; 🇺🇸 Anaheim, California, United States

Healthsouth Clinical Research; 🇺🇸 Desoto, Texas, United States

Dr. Martinez Medical Clinic; 🇺🇸 Moreno Valley, California, United States

Whittier Institute for Diabetes; 🇺🇸 La Jolla, California, United States

Richard Cherlin, M.D.; 🇺🇸 Los Gatos, California, United States

Clinical Research Group of North Georgia; 🇺🇸 Blairsville, Georgia, United States

Diabetes Center of the Southwest; 🇺🇸 Midland, Texas, United States

International Clinical Research Network; 🇺🇸 Chula Vista, California, United States

Pioneer Medical Group; 🇺🇸 Bellflower, California, United States

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States